Potters Heartburn Relief Plus Mixture
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Heartburn Relief Plus Mixture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral liquid contains:-
0.99 ml of extract (as liquid extract) from Meadowsweet Herb (Filipendula ulmaria
(L.) Maxim) (1:1) (equivalent to 0.99 g Meadowsweet herb)
Extraction Solvent: Water
0.374 ml of extract (as liquid extract) from Gentian Root( Gentiana lutea L.) (11)
(equivalent to 0.04g Gentian Root)
Extraction Solvent: Water
0.2 ml of extract (as liquid extract) from Euonymus Bark (Euonymus atropurpureus Jacq.) (1:5) (equivalent to 0.04 g Euonymus bark)
Extraction Solvent: 45% Ethanol v/v
Excipients:
5 ml of oral liquid contains 0.65 ml ethanol and 0.99 g sucrose. (See section
4.4 ‘Special warnings and precautions for use’.)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral liquid.
A dark reddish brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of indigestion, heartburn and flatulence, based on traditional use only.
For oral use only.
Adults and the elderly: Take one 5ml teaspoonful after meals three or four times a day.
Not recommended for children and adolescents under 18 years of age. (See section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen or do not improve after one week a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients, salicylates or any of the excipients. Peptic ulcer.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.
Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.
This medicinal product contains 13% v/v ethanol (alcohol), i.e. up to 520 mg per dose, equivalent to 13 ml beer, 5.4 ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
This medicinal product contains sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-glactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Not to be used concomitantly with salicylates and other NSAIDs without medical advice.
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).
The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.
Studies on fertility have not been carried out.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section 4.4 ‘Special warnings and precautions for use’.)
4.8 Undesirable effects
For Gentian root, gastrointestinal disorders have been observed, tachycardia and pruritus have been reported and headache may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
No cases of overdose have been reported.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (13 g in 100 ml; 26 g in 200 ml: equivalent to 0.4 and 0.8 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
For some xanthones which are among the constituents of Gentiana lutea, positive results were found in the AMES test (pre-incubation method). Assessment of preclinical safety requires further studies towards these effects.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol Tragacanth Glycerol Syrup (sucrose)
Peppermint Oil Fennel Oil
Infusion of Clove, Concentrated (cloves, ethanol and water)
Sodium Bicarbonate
Water
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
Amber glass bottle with child-resistant tamper evident EPE cap contained in cardboard carton: 90 ml, 150 ml, 200 ml or 250 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited 1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ
8 MARKETING AUTHORISATION NUMBER(S)
THR 44893/0013
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/04/2013
10 DATE OF REVISION OF THE TEXT
28/09/2015